http://www.legislation.gov.uk/uksi/2012/1916/regulation/39The Human Medicines Regulations 2012texttext/xmlenStatute Law DatabaseMEDICINES2026-04-09Expert Participation2026-03-31 These Regulations consolidate the law of the United Kingdom concerning medicinal products for human use (“products”) in respect of the topics described below. The Human Medicines Regulations 2012reg. 51(9)The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 1 para. 5reg. 1The Human Medicines Regulations 2012reg. 52(1)(a)(i)(ii) and wordsThe Human Medicines (Amendment etc.) (EU Exit) Regulations 2019reg. 57(2)reg. 1The Human Medicines Regulations 2012reg. 53(2)-(2C)The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019reg. 58(3)reg. 1The Human Medicines Regulations 2012reg. 53(2)(a)The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 1 para. 6(2)reg. 1The Human Medicines Regulations 2012Sch. 11 para. 1(1)(d)-(f)The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019reg. 63(2)(a)(ii)reg. 1The Human Medicines Regulations 2012Sch. 33A para. 57(2)The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 1 para. 10(3)(a)reg. 1The Human Medicines Regulations 2012Sch. 33A para. 57(3)The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 1 para. 10(3)(b)reg. 1The Human Medicines Regulations 2012Sch. 33A para. 57AThe Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Sch. 1 para. 10(4)reg. 1The Human Medicines Regulations 2012reg. 4AThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025art. 5art. 1(3)art. 2The Human Medicines Regulations 2012reg. 220AThe Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025art. 7(3)art. 1(3)art. 2The Human Medicines Regulations 2012reg. 346(2)(c)(xxviiieza)The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025art. 12(16)(a)art. 1(3)art. 2The Human Medicines Regulations 2012reg. 173(e)The Ionising Radiation (Medical Exposure) Regulations 2017Sch. 4 para. 2(2)(b)reg. 1The Human Medicines Regulations 2012reg. 240(2A)The Ionising Radiation (Medical Exposure) Regulations 2017Sch. 4 para. 2(3)(c)reg. 1The Human Medicines Regulations 2012reg. 240(6A)The Ionising Radiation (Medical Exposure) Regulations 2017Sch. 4 para. 2(3)(g)reg. 1 PART 3CHAPTER 2391This regulation applies in relation to any manufacturer's licence.2The licence holder must maintain such staff, premises, equipment and facilities for the handling, control, storage and distribution of medicinal products under the licence as are appropriate in order to maintain the quality of the medicinal products.3The licence holder must ensure that any arrangements made for the handling, control, storage and distribution of medicinal products are adequate to maintain the quality of the products.4Except in the case of an MM medicinal product or a POC medicinal product, the licence holder must not handle, control, store or distribute medicinal products on any premises other than those specified in the licence as approved by the licensing authority for the purpose.5Except in the case of an MM medicinal product or a POC medicinal product, the licence holder must inform the licensing authority before making a material alteration to the premises or facilities used under the licence, or to the purposes for which those premises or facilities are used.5AThe holder of a manufacturer’s licence (MM) must ensure that the medicinal products specified in the licence are not handled, controlled, stored or distributed on any premises other than the MM control site and the modular units specified in the MM master file.5BThe holder of a manufacturer’s licence (MM) must inform the licensing authority before making a material alteration to the premises or facilities at the MM control site, or to any modular unit specified in the MM master file, or to the purposes for which those premises or facilities are used.5CThe holder of a manufacturer’s licence (POC) must ensure that the medicinal products specified in the licence are not handled, controlled, stored or distributed on any premises other than the POC control site and those specified in the POC master file.5DThe holder of a manufacturer’s licence (POC) must inform the licensing authority before making a material alteration to the premises or facilities at the POC control site, or to the purposes for which those premises or facilities are used.5EParagraphs (5A) and (5C) do not apply to anything done in the course of the business of a hospital that consists of dealing with a medicine or making it ready for use for the purposes of its final supply or administration to a patient.6The licence holder must inform the licensing authority of any proposed change to—athe qualified person; andbany person named in the licence as having responsibility for quality control.7For the purposes of enabling the licensing authority to determine whether there are grounds for suspending, revoking or varying the licence, the licence holder must permit a person authorised in writing by the licensing authority to do anything that the licensing authority could have done for the purposes of verifying a statement made in an application for a licence.8In distributing a medicinal product by way of wholesale dealing, the licence holder must comply with the following as if they are a holder of a wholesale dealer’s licence—aregulations 43(1), (2) and (5), 43ZA and 44(5) and (6).b. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pt. 3 heading and Pt. 3 Ch. 1 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4Pt. 3 Ch. 2 heading inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4Reg. 39(8) substituted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 9Reg. 39(8)(a): full stop substituted for word (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 16(a)Reg. 39(8)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 16(b)Reg. 39(5A)-(5E) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 15(3)Words in reg. 39(4) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 15(2)Words in reg. 39(5) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 15(2)